Clinical Trials Directory

Trials / Completed

CompletedNCT04322500

Probiotics for Chalaziosis Treatment in Children

Intestinal Microbiota: a New Target for Chalaziosis Treatment in Children

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (actual)
Sponsor
University of Molise · Academic / Other
Sex
All
Age
3 Years – 14 Years
Healthy volunteers
Not accepted

Summary

There is growing evidence encouraging the use of probiotics in many conditions in children. The aim of the investigator's study is to define the possible beneficial impact of probiotics on paediatric patients affected by chalaziosis.

Detailed description

Prospective comparative pilot study on 26 children suffering from chalaziosis. They will be randomly divided in two groups. One group will receive conservative treatment and the other one will receive conservative treatment and a daily supplementation of probiotics. All patients will be evaluated at 2-week intervals for 3 months. If the lesion will not disappear or decrease in size to 1 mm or less in diameter on subsequent visits, the same procedure will be repeated for another 3-months cycle. The follow up periods extend from 3 to 6 months according to the results.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTprobioticsuse specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis
OTHERconservative treatmentlid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days

Timeline

Start date
2019-02-01
Primary completion
2020-02-29
Completion
2020-02-29
First posted
2020-03-26
Last updated
2020-05-05
Results posted
2020-04-24

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT04322500. Inclusion in this directory is not an endorsement.